Vascular sealant delivery device and sheath introducer and method

ABSTRACT

A sheath introducer is inserted through the skin and into a body lumen, e.g., the femoral artery, for a medical procedure. Upon completion of the medical procedure, the sheath introducer is partially withdrawn from the body lumen so that at least one through-wall hole in a body region of the sheath introducer is positioned outside the body lumen, but under the skin. An opening in a distal end tip of the sheath introducer is sealed so that no blood is flowing into the sheath introducer the after sheath introducer is partially withdrawn. A surgical sealant is injected into the sheath introducer and flows out of the at least one through-wall hole and surrounds the access site. After injection of the surgical sealant, the sheath introducer is removed. The surgical sealant seals the puncture and minimizes any blood flow from the body lumen through the puncture.

RELATED APPLICATIONS

This application is a Divisional of U.S. application Ser. No. 10/348,406filed Jan. 20, 2003, all of which is incorporated herein by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to closure devices for puncturesites in a body and more particularly to closure of puncture sitesassociated with percutaneous access to blood vessels in a human body oran animal body associated with introduction of a device into the bloodvessel to accomplish a medical procedure.

2. Description of Related Art

Techniques for introducing a sheath introducer into a body lumen for asubsequent introduction of a device used to perform a medical procedureare well known. Introduction of the sheath introducer produces apuncture in the body lumen, e.g., a puncture in the femoral artery, atthe access site.

At the conclusion of the medical procedure, the device is withdrawnthrough the sheath introducer and then the sheath introducer iswithdrawn through the skin and from the body lumen. Various devices havebeen suggested for closing the puncture wound left in the body lumen.The devices are either complex, or rely upon techniques to isolate thepuncture that are not reliable. While the problem of closing thepuncture wound is recognized, a reliable, safe, easy to use device andmethod are still needed.

SUMMARY OF THE INVENTION

According to one embodiment of the present invention, a structureincludes a sheath introducer having a distal end tip. The sheathintroducer also includes a body region having a wall bounded by an outerwall surface of the sheath introducer and by an inner wall surface ofthe sheath introducer.

The body region is oriented about a longitudinal axis of the body regionand is at about a predefined distance from the distal end tip. The bodyregion can have some longitudinal extent and so is located at about thepredefined distance. The body region includes at least one through-wallhole extending from the outer wall surface to the inner wall surface.The at least one through-wall hole is included in a plurality ofthrough-walls holes in the body region.

The through-wall hole has a longitudinal axis that is oriented at anangle to the longitudinal axis of the body region. In one embodiment ofthe through-wall hole, the angle is about a 90° angle. In anotherembodiment of the through-wall hole, the angle is other than a 90°angle.

In still another embodiment of the through-wall hole, the at least onethrough-wall hole has a uniform cross section along the longitudinalaxis of the at least one through-wall hole. In yet still anotherembodiment of the through-wall hole, the at least one through-wall holehas a non-uniform cross section along the longitudinal axis of the atleast one through-wall hole.

The structure also includes a dilator having a shaft with a distal end.A dilator plug is formed about the shaft and extends from about thedistal end of the shaft to about a predefined distance from the distalend of the shaft. Following insertion of the dilator into the sheathintroducer, the dilator plug forms a seal in the distal end of thesheath introducer. The predefined distance from the distal end of theshaft is selected so that the dilator plug does not block the at leastone through-wall hole.

The structure further includes a balloon clamp catheter extendingthrough the sheath introducer. The structure also includes a guidewireextending through the sheath introducer. A surgical sealant deliverysystem is coupled to the sheath introducer to inject a surgical sealantinto the sheath introducer. The sheath introducer includes a pluralityof depth indicators on the outer surface.

A method for sealing a puncture of a body lumen created by using asheath introducer plugs a distal end tip of a sheath introducer having athrough-wall hole. The sheath introducer is positioned so that thethrough-wall hole is outside a body lumen and a surgical sealant isinjected into the sheath introducer that in turn flows out the at leastone through-wall hole.

The method also includes blocking the body lumen using a balloon clampcatheter. The sheath introducer is removed from the body lumen followingthe injecting. The balloon clamp catheter is removed from the body lumenafter the sheath introducer is removed.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is an illustration of a system used to inject a surgical sealantexterior to a puncture in a body lumen with the system positioned forsealant injection.

FIG. 1B illustrates the system of FIG. 1A following injection of thesurgical sealant.

FIG. 1C illustrates the surgical sealant sealing the puncture afterremoval of the system of FIGS. 1A and 1B.

FIG. 2A is a cross-section view of one embodiment of a distal end of asheath introducer that includes a distal end tip and a body regionhaving a plurality of through-walls holes located at about a predefineddistance from the distal end tip.

FIG. 2B is a cross-section view of another embodiment of a distal end ofa sheath introducer that includes a distal end tip and a body regionhaving a plurality of through-walls holes located at about a predefineddistance from the distal end tip.

FIG. 2C is a cross-section view of still another embodiment of a distalend of a sheath introducer that includes a distal end tip and a bodyregion having a plurality of through-walls holes located at about apredefined distance from the distal end tip.

FIG. 2D is a cross-section view of still yet another embodiment of adistal end of a sheath introducer that includes a distal end tip and abody region having a plurality of through-walls holes located at about apredefined distance from the distal end tip.

FIG. 3A is an illustration of a system that includes a sheath introducerwith at least one through-wall hole, a dilator with a plug, a balloonclamp catheter, and a spring guidewire in an initial position of apuncture sealing process.

FIG. 3B is an illustration of the system of FIG. 3A in a position forsurgical sealant injection in the puncture sealing process.

FIG. 3C is an illustration of the system of FIG. 3B that includes aclamp for maintaining the position of the sheath introducer during thesurgical sealant injection in the puncture sealing process.

FIG. 3D is an illustration of the system of FIG. 3C following surgicalsealant injection in the puncture sealing process.

FIG. 3E is an illustration of the system of FIG. 3D following removal ofthe sheath introducer and dilator in the puncture sealing process.

FIG. 4 is a process flow diagram of a puncture sealing process.

FIG. 5 is an illustration of a dilator and plug used in of the system ofthis invention.

In the drawings and the following detailed description, elements withthe same reference numeral are the same or equivalent elements. Also,the first digit of a reference numeral for an element is the figurenumber of the figure in which that element first appears.

DETAILED DESCRIPTION

According to one embodiment of the present invention, a sheathintroducer 100 (FIG. 1A) is inserted through skin 101 and into a bodylumen 102, e.g., the femoral artery, for a medical procedure. Uponcompletion of the medical procedure, sheath introducer 100 is partiallywithdrawn from body lumen 102 so that at least one through-wall hole 105in a body region of sheath introducer 100 is positioned outside bodylumen 102, but under skin 101.

An opening in a distal end tip 106 of sheath introducer 100 is sealed bya plug 110 so that no blood is flowing into sheath introducer 100 aftersheath introducer 100 is partially withdrawn. A surgical sealant isinjected into sheath introducer 100 by a surgical sealant injectionsystem 120. Surgical sealant 115 flows out of at least one through-wallhole 105 and surrounds the access site. (FIG. 1B.)

After injection of surgical sealant 115, sheath introducer 100, plug110, and flexible guidewire 130 are removed. Surgical sealant 115 sealsthe puncture and minimizes any blood flow from body lumen 102 throughthe puncture (FIG. 1C).

This method and novel sheath introducer apply the surgical sealant toexactly the area to be closed. The method and sheath introducer can beused with patients with poor blood-clotting capability. The prior artproblems associated with the access site are minimized. No specializedmembranes or membrane delivery devices are required to form the seal. Asexplained more completely below, in one embodiment, if bleeding occursfollowing the surgical sealant injection procedure, the physician caneasily recover.

A standard sheath introducer is modified by forming at least onethrough-wall hole 105 in a body of the sheath introducer. At least onethrough-wall hole 105 extends from an outer surface of the body ofsheath introducer 100 to an inner surface of the body of sheathintroducer 100.

Sheath introducer 200A (FIG. 2A) has a body region 210A that includes aplurality of through-wall holes 205AA, 205AB, 205AC. Plurality ofthrough-wall holes 205AA, 205AB, 205AC are located at about a predefineddistance X from a distal end tip 206A of sheath introducer 200A.

Body region 210A has an outer surface 201A separate and removed from aninner surface 202A. Outer surface 201A and inner surface 202A areorientated about a longitudinal axis 203A.

Body region 210A is cylindrical in shape. Alternatively, body region210A is ellipsodal. The particular shape of body region 210A is notessential to this invention.

Each of through-wall holes 205AA, 205AB, 205AC (FIG. 2A) has alongitudinal axis 215AA, 215AB, 215AC (not shown) that is orientated ata predefined angle αAi, where i is A, B, C, with respect to longitudinalaxis 203A of body region 210A. Predefined angle αAi can be 90°, 60°, orany other suitable angle. Predefined angle αAi can be the same for someor all through-wall holes, or different for each through-wall hole. Forexample, each of through-wall holes 205AA, 205AB, 205AC is orientated atthe same predefined angle α1 to longitudinal axis 203A of region 204A,which in the embodiment of FIG. 2A is 90°.

Sheath introducer 200B (FIG. 2B) has a body region 210B that includes aplurality of through-wall holes 205BA, 205BB, 205BC. Plurality ofthrough-wall holes 205BA, 205BB, 205BC are located at about a predefineddistance X from a distal end tip 206B of sheath introducer 200B.

Body region 210B has an outer surface 201B separate and removed from aninner surface 202B. Outer surface 201B and inner surface 202B areorientated about a longitudinal axis 203B.

In sheath introducer 200B (FIG. 2B), not all of through-wall holes205BA, 205BB, 205BC are orientated at the same predefined angle tolongitudinal axis 203B of body region 210B. For example, through-wallhole 205BA (FIG. 2B) has a longitudinal axis 215BA that is orientated ata predefined angle α2 with respect longitudinal axis 203B of body region210B. Through-wall hole 205BC (FIG. 2B) has a longitudinal axis 215BCthat is orientated at a predefined angle α3 with respect longitudinalaxis 203B of body region 210B.

In general, through-wall holes 205AA, 205AB, 205AC, 205BA, 205BB, 205BCare oriented to facilitate disbursement of the sealant so that uponwithdrawal of sheath introducer 100, the sealant seals the puncture. Thenumber of through-wall holes, the orientation of the through wall-holes,the size and shape of the through wall-holes are determined empirically.

In FIGS. 2A and 2B, each of through-wall holes 205AA, 205AB, 205AC,205BA, 205BB, 205BC has a uniform circular cross-section about thelongitudinal axis of the through-wall hole. Through-wall holes 205CA and205CC (FIG. 2C) are tapered. Hence, the through-wall hole has a circularcross section that varies along the longitudinal axis of thethrough-wall hole. In FIG. 2C, the circular cross section increasesgoing from inner surface 202C to outer surface 201C. Alternatively, thecircular cross section decreases going from inner surface 202C to outersurface 201C.

Sheath introducer 200C (FIG. 2C) has a body region 210C that includes aplurality of through-wall holes 205CA, 205CB, 205CC. Plurality ofthrough-wall holes 205CA, 205CB, 205CC are located at about a predefineddistance X from a distal end tip 206C of sheath introducer 200C.

Body region 210C has an outer surface 201C separate and removed from aninner surface 202C. Outer surface 201C and inner surface 202C areorientated about a longitudinal axis 203C.

Sheath introducer 200D (FIG. 2D) has a body region 210D that includes aplurality of through-wall holes 205DA, 205DB, 205DC. Plurality ofthrough-wall holes 205DA, 205DB, 205DC are located at about a predefineddistance X from a distal end tip 206D of sheath introducer 200D.

Body region 210D has an outer surface 201D separate and removed from aninner surface 202D. Outer surface 201D and inner surface 202D areorientated about a longitudinal axis 203D.

In FIG. 2D, each of through-wall holes 205DA, 205DB, 205DC has a uniformelliptical cross-section about the longitudinal axis of the through-wallhole. In view of this disclosure, other through-wall hole shapesincluding ovals, rectangles, squares, etc. could be used. Also, acombination of shapes and angular orientations of the longitudinal axesof the through-holes could be used. A grid of through-wall holes couldbe formed about body region 210D. Irrespective of the pattern, shape,number, and orientation of the through-wall holes included in bodyregion 210D, body region 210D includes at least one through-wall hole.

A system 350 (FIG. 3A) includes sheath introducer 300 with a body regionthat includes at least one through-wall hole, e.g., holes 305A, 305B, adilator 320 including a dilator plug 310, a balloon clamp catheter 340,a low profile spring guidewire 330, a sealant injection system 120 (FIG.1A), and a sealant. System 350 is used with a puncture sealing process400 (FIG. 4).

In remove devices operation 401, all devices used in the medicalprocedure are removed from sheath introducer 300. Upon completion ofremove devices operation 401, a low profile spring guidewire 330 isinserted into lumen 302, which is for example the femoral artery,through sheath introducer 300 in insert guidewire operation 402. Lowprofile spring guidewire 330 is a 0.035-inch (0.089 cm) spring guidewireand alternatively is a 0.025-inch (0.064 cm) spring guidewire.

Following completion of insert guidewire operation 402, balloon clampcatheter 340 and dilator 320 with dilator plug 310 are inserted intosheath introducer 300 in insert balloon and dilator operation 403. FIG.5 is a more detailed illustration of dilator 320 with dilator plug 310.

In the example of FIG. 5, dilator 320 includes a dilator shaft 520 and adilator hub 525. Dilator hub 525 functions as a stop. Shaft 520 ishollow so that an open inner lumen is maintained when dilator 320 andsheath introducer 300 are removed. Shaft 520 and dilator hub 525 aremade from a standard material such as polyethylene.

Dilator plug 310 is formed, e.g., molded, about an outer surface ofshaft 520. Dilator plug 310 extends about a predefined distance Y from adistal end of shaft 520. In one embodiment, distance Y is selected sothat dilator plug 310 extends at least to distal end 306 of sheathintroducer 300 and terminates so that dilator plug 310 does not blockthrough-wall holes 305A, 305B when dilator 320 is in the deployedposition.

Dilator plug 310 is made from a hydrogel material or any other materialthat swells to form a hermetic seal with inner surface 304 at the distalend of sheath introducer 300. Immediately before the start of insertballoon and dilator operation 403, dilator plug 310 is wet with salineto start the swelling of dilator plug 310, and then immediately insertedinto the sheath.

To assist in positioning dilator plug 310 properly within sheathintroducer 300 in insert balloon and dilator operation 403, a stop (Seeelement 125 in FIG. 1A.) is mounted on a proximal end of dilator 320 sothat dilator plug 310 is positioned properly at the distal end of sheathintroducer 300, as illustrated in FIG. 3A. The stop may be removable.Typically, dilator 320 is configured for a specific sheath introducer300 so that dilator plug 310 is properly positioned.

Guidewire 330 and balloon clamp catheter 340 fit within inner lumen 521of dilator 320. Balloon clamp catheter 340 fits over guidewire 330 andin this embodiment has a size of 3 to 4 French. The balloon ismanufactured from a compliant material and is sized to occlude entirefemoral artery 302 when inflated. The compliant material helps tominimize femoral artery trauma.

Upon completion of insert balloon and dilator operation 403, system 350is configured as illustrated in FIG. 3A. When dilator plug 310 swells toseal the distal end of sheath introducer 300, blood flow is blocked intodistal end tip 306. However, as described above, dilator plug 310transitions to shaft 520 of dilator 320 so that though-wall holes 305A,305B are not blocked. Hence, blood flows into sheath introducer 300 viathrough-wall holes 305A, 305B up to a side port (not shown) of system350.

In obtain back-bleed operation 404, the side port is opened to obtain aback-bleed. In position sheath operation 405, sheath introducer 300 isslowly withdrawn from femoral artery 302. When the back-bleed stops,through-wall holes 305A, 305B are positioned outside the inner wall offemoral artery 302, e.g., external to the body lumen, as illustrated inFIG. 3B.

At this point, it is important to assure that sheath introducer 300 doesnot move. In FIG. 3C, a clamp 370 is placed about sheath introducer 300at the level of skin 301. Also, there may be graduations marks on outersurface 303, i.e., a plurality of depth indicators, that can be used toassure that sheath introducer 300 is not moved after the back-bleedstops. The graduations may be used with or without clamp 370.

After sheath introducer 300 is positioned so that the back-bleed isstopped, the balloon of balloon clamp catheter is inflated in inflateballoon operation 406. The inflated balloon stops flow through femoralartery 302 and acts like manual compression.

In inject sealant operation 407, sealant injection system 120 is used toinject a surgical sealant 315 (FIG. 3D) through sheath introducer 300and out through-wall holes 305A, 305B into an area about sheathintroducer 300 outside femoral artery 302.

The surgical sealant is in either a fluid or a slurry form. Surgicalsealants are known to those of skill in the art. Suitable surgicalsealants include fibrin glue, collagen slurries, and cellulose slurries.There are also commercial sealants available from companies such Davol,Inc. that provides, for example, Avitene® Microfibrillar Collagen. Thesurgical sealant is non-adherent or at most very weakly adherent tosheath introducer 300.

Upon completion of inject sealant operation 407, sheath introducer 300and dilator 320 are removed in remove sheath and dilator operation 407.At this point, surgical sealant 315 has not set up completely and soflows to fill the void left by sheath introducer 300.

In apply pressure operation 409, pressure is applied at the skin levelwhile surgical sealant 315 hardens. Typically, this is done for severalminutes. The time is determined by the type of surgical sealant 315.Surgical sealant 315 should be firm enough to curtail bleeding but notso hard as to prevent removal of balloon clamp catheter 340 andguidewire 330.

Upon completion of apply pressure operation 409, the balloon is deflatedin close balloon operation 410. After the balloon is deflated, bleedingis checked in bleeding check operation 411. If bleeding is detected, thesheath and dilator are reinserted in reinsert sheath operation 412 andthen operations 404 to 411 are repeated. If bleeding is not detected,balloon clamp catheter 340 is removed in remove balloon clamp operation413.

Following removal of balloon clamp catheter 340, bleeding is againchecked in bleeding check operation 415. If bleeding is detected, thesheath introducer is reinserted in reinsert sheath operation 415 andoperations 403 to 414 repeated as appropriate. If no bleeding isdetected, the guidewire is removed in remove wire operation 416 andprocess 400 is completed.

The puncture in femoral artery 302 has been sealed with the surgicalsealant as illustrated in FIG. 1C. The surgical sealant has been appliedto exactly the area to be closed. Also, process 400 does not depend uponthe clotting capability of the patient.

Structure 350 and process 400 reduces access site complications.Therefore, a patient, who in the past might suffer such complications,no longer must undergo an invasive surgery to prevent the injury orinjuries associated with such complications.

1. A method comprising: plugging a distal end tip of a sheath introducerhaving at least one through-wall hole with a dilator plug of a dilatorwherein said dilator is inserted through said sheath introducer;positioning said sheath introducer so that said at least onethrough-wall hole is outside a body lumen; injecting a surgical sealantinto said sheath introducer, wherein said surgical sealant passes fromsaid sheath introducer through said at least one through-wall hole,wherein the method further comprises: inserting, prior to said plugging,said positioning, and said injecting, said sheath introducer into saidbody lumen; performing, prior to said plugging, said positioning, andsaid injecting, a medical procedure, using a device inserted into saidbody lumen through said sheath introducer; and removing, prior to saidplugging, said positioning, and said injecting and following completionof said performing said medical procedure, said device from said bodylumen and from said sheath introducer.
 2. The method of claim 1 furthercomprising: blocking said body lumen using a balloon clamp catheter. 3.The method of claim 2 further comprising: removing said sheathintroducer from said body lumen following said injecting.
 4. The methodof claim 3 further comprising: removing said balloon clamp catheter fromsaid body lumen.
 5. The method of claim 1 further comprising: removingsaid sheath introducer from said body lumen following said injecting. 6.The method of claim 1 wherein said positioning further comprises:obtaining a back bleed; and removing said sheath introducer from saidbody lumen until said back bleed stops.
 7. The method of claim 6 furthercomprising: maintaining a position of said sheath introducer, followingcompletion of said positioning, for said injecting.
 8. A methodcomprising: inserting a sheath introducer into a body lumen; performinga medical procedure using a device inserted into said body lumen throughsaid sheath introducer; removing said device from said body lumen andsaid sheath introducer; plugging, following said inserting, saidperforming, and said removing, a distal end tip of said sheathintroducer with a dilator plug of a dilator, wherein said sheathintroducer includes at least one through-wall hole, and further whereinsaid dilator is inserted through said sheath introducer; positioningsaid sheath introducer so that said at least one through-wall hole isoutside said body lumen, wherein said positioning comprises: obtaining aback bleed; and withdrawing said sheath introducer from body lumen untilsaid back bleed stops; and injecting a surgical sealant into said sheathintroducer, wherein said surgical sealant passes from said sheathintroducer through said at least one through-wall hole .
 9. The methodof claim 8 further comprising: maintaining a position of said sheathintroducer, following completion of said positioning, for saidinjecting.